FDA WARNING_LETTER - Prostar, Inc. - November 17, 2010

An FDA inspection of Prostar, Inc. (Farmington, CT) from November 1-17, 2010, revealed multiple Current Good Manufacturing Practice (cGMP) violations for dietary supplements (21 CFR Part 111). The inspection found Super Complete formula multivitamin tablets, Ultra Ripped capsules, and Higher Power (HP) 100% Whey Powder protein powder to be adulterated.

Key violations include: 1. Failure to establish product specifications for identity and strength of finished batches (21 CFR 111.70(e)) for Ultra Ripped and Super Complete products. The company's response was inadequate, lacking documentation and addressing only testing, not specification establishment. 2. Failure to conduct identity testing for each dietary ingredient before use (21 CFR 111.75(a)(1)). Specifically, most dietary ingredients for Ultra Ripped and Super Complete were not tested for identity, and the firm practiced "skip lot testing." The response was inadequate, lacking specifics and documentation of corrective actions. 3. Quality control personnel approved and released dietary supplements (Super Complete) that did not meet product specifications, as out-of-specification results for strength were found after release (21 CFR 111.123(b)(1)). 4. Failure to establish and follow written procedures for quality control operations, specifically regarding approving/releasing finished batches based